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KYNTHEUM Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Kyntheum 210 mg solution for injection in pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. 1 ml solution contains 140 mg brodalumab. Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary ...

Pharmaceutical form

Solution for injection (injection). The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles.

Therapeutic indications

Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

Posology and method of administration

Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology The recommended dose is 210 mg administered by subcutaneous ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active Crohns disease. Clinically important active infections (e.g. active tuberculosis, see section 4.4).

Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Crohns disease There is limited ...

Interaction with other medicinal products and other forms of interaction

Live vaccines should not be given concurrently with Kyntheum (see section 4.4). The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment. Pregnancy There are no or limited ...

Effects on ability to drive and use machines

Kyntheum has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in all Kyntheum-treated patients were arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal ...

Overdose

Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors ATC code: L04AC12 Mechanism of action Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with ...

Pharmacokinetic properties

Absorption Based on population pharmacokinetic modelling, the estimated accumulation ratio after 20 weeks of dosing is 2.5-fold. In moderate to severe plaque psoriasis patients following a single subcutaneous ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints and assessment of fertility-related endpoints), and ...

List of excipients

Proline Glutamate Polysorbate 20 Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 4 years.

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Kyntheum may be stored at room temperature (up to 25°C) once, in the outer ...

Nature and contents of container

1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½" needle, covered with an elastomeric needle cap. Kyntheum is available in unit packs containing 2 pre-filled syringes and ...

Special precautions for disposal and other handling

Kyntheum is a sterile solution for injection in pre-filled syringe. Each pre-filled syringe is for single use only. The Instructions for Use should be consulted for detailed instructions on administration ...

Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750, Ballerup, Denmark

Marketing authorization number(s)

EU/1/16/1155/001 EU/1/16/1155/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 July 2017

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